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Drug Recalls

Last updated

Every drug recall in FDA enforcement reports from the last three years, plus older recalls that are still open. Filter by severity, status or medicine, and check the lot numbers on your package.

0 Class I (most serious) drug recalls reported in the last 30 days.

2 recalls

  • Class II Ongoing

    Doxycycline Hyclate Tablets, USP 100 mg*, 500-count bottle, Rx Only, Distributed by: Acella Pharmaceuticals, LLC, Alpharetta, GA 30005, NDC 42192-501-05.

    Reason: Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.

    Acella Pharmaceuticals, LLC · Doxycycline Hyclate

    Lots, distribution and details
    Lots / codes
    Lot #: P24ZLK1, Exp 5/31/2027
    Distribution
    Nationwide in the USA
    Quantity
    4,680 500-count bottles
    Recall started
    September 29, 2025 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0014-2026
  • Class II Terminated

    Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur – 441 108, INDIA. NDC 68180-652-08

    Reason: CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.

    CARDINAL HEALTHCARE · Doxycycline

    Lots, distribution and details
    Lots / codes
    Batch G104819
    Distribution
    Nationwide USA
    Quantity
    1 unit
    Recall started
    January 26, 2022 (Voluntary: Firm initiated)
    Severity
    Could cause temporary or medically reversible health problems; serious harm is unlikely.
    FDA recall number
    D-0178-2024

Have this medicine at home? Compare the lot number and expiry date on your package with the recall. Do not stop taking a prescribed medicine on your own — stopping suddenly can be riskier than the recalled lot. Your pharmacist can check it and usually swap it for an unaffected one.

What the recall classes mean

  • Class I Most serious: use could cause serious health problems or death.
  • Class II Could cause temporary or medically reversible health problems; serious harm is unlikely.
  • Class III Not likely to cause health problems — for example a labelling or packaging fault.

Source: FDA Enforcement Report, via openFDA. Updated here twice a day; last update October 31, 2026 14:40. openFDA data are not validated for clinical use — confirm with the FDA source or your pharmacist.

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